GenFleet Therapeutics (Shanghai) (2595) Study result presentation summary

NSCLC efficacy

• At 600 mg once daily, ORR was 59.2% (42/71) and confirmed ORR 52.1% (37/71); DCR was 93.0%.

• Median time to response was 1.4 months and median duration of response was 8.3 months (95% CI: 6.3, NA).

• Median PFS was 8.3 months (95% CI: 6.8, NA); it was 9.6 months in taxane-naïve patients and 8.1 months in taxane-pretreated patients.

• Median OS was not reached; 12-month OS rate was 77.0% (95% CI: 66.9%, 88.7%) at median follow-up of 11.2 months.

• Among 9 patients with brain metastases and post-treatment evaluation, ORR was 55.6% (5/9); no brain lesions were selected as target lesions.

NSCLC safety

• At 600 mg once daily (N=75), grade ≥3 TRAEs occurred in 41.3%; TRAEs led to discontinuation in 4.0%, dose reduction in 25.3%, and interruption in 37.3%.

• Grade ≥3 TEAEs occurred in 56.0%; TEAEs led to discontinuation in 8.0%, dose reduction in 25.3%, interruption in 44.0%, and death in 6.7%.

• Common TRAEs were gastrointestinal, hematological and transaminitis; most were grade 1 or 2 and recovered with supportive treatment, with no new safety signals reported.

• Median treatment exposure was 5.3 months (range: 0.5–16.1); mean relative dose intensity was 89.8%.

Development progress and study context

• GFH375 received domestic breakthrough therapy designations for NSCLC in Feb 2026 and PDAC in Apr 2026; a global phase III PDAC study started in Nov 2025 and an NSCLC phase III study in Jul 2026.

• The 600 mg once-daily NSCLC study reported confirmed ORR of 52.1% and DCR of 93%, versus 52% and 93%, respectively, for RMC-9805 in a separate study; these are cross-trial results.

• Study populations differed: 42.7% of GFH375 patients had received 2 prior lines and 22.7% had received ≥3, while the RMC-9805 study included patients with 1–2 prior lines; 38.7% of GFH375 patients had prior taxane use.

• Three KRAS G12D inhibitors were described as having entered phase III NSCLC studies; GFH375 was presented at 600 mg once daily with 52.1% confirmed ORR and 93% DCR.